Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

NCT06599476 | Active Not Recruiting FDA Device

• 1 other identifier: 1372621
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement. The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer. Study visits:

• Screening
• Spacer placement
• Treatment planning simulation
• End of the radiation treatment
• 1,3,and 6-months FU visits.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Dosimetry

  Dose-volume histogram (DVH) including the percent of the rectal volume receiving 70 Gy

  6 months

Study Arms (1)

BioProtect Balloon Implant System

EXPERIMENTAL

The Bio Protect Balloon Implant System (BioProtectLtd.,TzurYigal,Israel) is an Food and Drug Administration approved rectal spacer that consists of a solid biodegradable balloon-shaped material composed of poly L-Lactide-co-caprolactone

Device: BioProtect Balloon Implant™ System

Interventions

BioProtect Balloon Implant™ System DEVICE

The BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, and by creating this space, to reduce the radiation dose delivered to the anterior rectum. The balloon is inserted into the perirectal space and inflated to its pre-defined size. The Balloon is made of biodegradable materials that maintain the space for the entire course of prostate radiation treatment and are absorbed by the patient's body over time

BioProtect Balloon Implant System

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with prostate cancer ≥ 18 years of age.
• Patients are in one of the following risk groups:
• T1-T3 prostate cancer with no posterior extra capsular extension
• Gleason score ≤ 7
• Planned for radiation treatment with rectal spacer.
• Ability to understand and the willingness to sign a written informed consent form.

You may not qualify if:

• Metastatic disease.
• Previously treated localized adenocarcinoma of the prostate.
• Active Inflammatory bowel disease requiring treatment with steroids.
• Prior total prostatectomy.
• Current urinary tract infection.
• Acute or chronic prostatitis.

Sponsors & Collaborators

• Advanced Radiation Centers of New York: lead

Study Sites (1)

Advanced Radiation Centers of New York

New Hyde Park, New York, 11042, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Shawn Zimberg, Radiation Oncology Medical Director, Radiation Oncology

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 19, 2024
• Study Start: May 21, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2024-08

Locations

US (1)